Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TELIGEN FAMILY OF ICDS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S167 |
Date Received | 04/30/2008 |
Decision Date | 05/08/2008 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATES TO THE PROGRAMMER SW MODEL 2868 V1.02 AND PULSE GENERATOR FIRMWARE V1.04.0, PATCH V1.00 FOR THE TELIGEN AND COGNIS FAMILIES OF DEVICES. |
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